4274 Federal Register / Vol. 75, No. 17 / Wednesday, January 27, 2010 / Rules and Regulations 

more than 30 days, or both. Nothing 

contained in these rules and regulations 

shall be construed to abrogate any other 

Federal laws or regulations or any State 

and local laws and regulations 

applicable to any area in which the 

property is situated. 

* * * * * 

Stanley F. Mires, 

Chief Counsel, Legislative. 

[FR Doc. 2010–1643 Filed 1–26–10; 8:45 am] 

BILLING CODE 7710–12–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0273; FRL–8807–2] 

Novaluron; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of novaluron in 

or on multiple commodities discussed 

later in this document. Additionally, 

this regulation removes the established 

tolerance on tomato, as it is included as 

a member in ‘‘vegetable, fruiting, group 

8’’. Interregional Research Project 

Number 4 (IR-4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

January 27, 2010. Objections and 

requests for hearings must be received 

on or before March 29, 2010, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0273. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Laura Nollen, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7390; e-mail address: 

nollen.laura@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Get Electronic Access to 

Other Related Information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

cite at http://www.gpoaccess.gov/ecfr. 

To access the OPPTS harmonized test 

guidelines referenced in this document 

electronically, please go to http:// 

www.epa.gov/oppts and select ‘‘Test 

Methods & Guidelines’’ on the left-side 

navigation menu. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2009–0273 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before March 29, 2010. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2009–0273, by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Petition for Tolerance 

In the Federal Register of June 10, 

2009 (74 FR 27538) (FRL–8417–7), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 9E7546) by IR-4, 

500 College Road East, Suite 201W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.598 be 

amended by establishing tolerances for 

residues of the insecticide novaluron, N- 

[[[3-chloro-4-[1,1,2-trifluoro-2-

(trifluoromethoxy)ethoxy]phenyl]

amino]carbonyl]-2,6-difluorobenzamide, 

in or on berry, low growing, subgroup 

13-07G at 0.50 parts per million (ppm); 

Swiss chard at 12 ppm; bean, snap, 

succulent at 0.60 ppm; bean, dry at 0.20 

ppm; vegetable, cucurbit, group 9 at 

0.25 ppm; and the following 

commodities at 1.1 ppm: cocona; 

eggplant, African; eggplant, pea; 


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eggplant, scarlet; goji berry; huckleberry, 

garden; martynia; naranjilla; okra; 

roselle; sunberry; tomato, bush; tomato, 

currant; tomato, tree; and vegetable, 

fruiting, group 8. That notice referenced 

a summary of the petition prepared on 

behalf of IR-4 by Makhteshim-Agan of 

North America, Inc., the registrant, 

which is available to the public in the 

docket, http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has revised 

several of the proposed tolerance levels. 

Additionally, the Agency has revised 

the entry for berry, low growing, 

subgroup 13-07G to exclude lowbush 

blueberry. The reasons for these changes 

are explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue....’’ 

Consistent with section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for the petitioned-for 

tolerances for residues of novaluron on 

vegetable, fruiting, group 8 at 1.0 ppm; 

vegetable, cucurbit, group 9 at 0.15 

ppm; berry, low growing, subgroup 13- 

07G, except lowbush blueberry at 0.45 

ppm; cocona at 1.0 ppm; eggplant, 

African at 1.0 ppm; eggplant, pea at 1.0 

ppm; eggplant, scarlet at 1.0 ppm; goji 

berry at 1.0 ppm; huckleberry, garden at 

1.0 ppm; martynia at 1.0 ppm; naranjilla 

at 1.0 ppm; okra at 1.0 ppm; roselle at 

1.0 ppm; sunberry at 1.0 ppm; tomato, 

bush at 1.0 ppm; tomato, currant at 1.0 

ppm; tomato, tree at 1.0 ppm; bean, 

snap, succulent at 0.60 ppm; bean, dry, 

seed at 0.30 ppm; and Swiss chard at 12 

ppm. EPA’s assessment of exposures 

and risks associated with establishing 

tolerances follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

Novaluron has low acute toxicity via 

the oral, dermal and inhalation routes of 

exposure. It is not an eye or skin irritant 

and is not a dermal sensitizer. In 

subchronic and chronic toxicity studies, 

novaluron primarily produced 

hematotoxic effects such as 

methemoglobinemia, decreased 

hemoglobin, decreased hematocrit, and 

decreased RBCs (or erythrocytes) 

associated with increased 

erythropoiesis. Increased spleen weights 

and/or hemosiderosis in the spleen were 

considered to be due to enhanced 

removal of damaged erythrocytes and 

not to an immunotoxic effect. 

There was no maternal or 

developmental toxicity seen in the rat 

and rabbit developmental toxicity 

studies up to the limit doses. In the 2– 

generation reproductive toxicity study 

in rats, both maternal and offspring 

toxicity were evidenced by enlargement 

of the spleen. Reproductive toxicity 

(decreases in epididymal sperm counts 

and increased age at preputial 

separation in the F1 generation) was 

observed only in males. 

Signs of neurotoxicity were seen in 

the rat acute neurotoxicity study at the 

limit dose, including clinical signs 

(piloerection, fast/irregular breathing), 

functional observation battery (FOB) 

parameters (head swaying, abnormal 

gait) and neuropathology (sciatic and 

tibial nerve degeneration). No signs of 

neurotoxicity or neuropathology were 

observed in the subchronic 

neurotoxicity study in rats or in any 

other subchronic or chronic toxicity 

study in rats, mice or dogs. Therefore, 

there is no concern for neurotoxicity 

resulting from exposure to novaluron. 

There was no evidence of 

carcinogenic potential in either the rat 

or mouse carcinogenicity studies and no 

evidence of mutagenic activity in the 

submitted mutagenicity studies, 

including a bacterial (Salmonella, E. 

coli) reverse mutation assay, an in vitro 

mammalian chromosomal aberration 

assay, an in vivo mouse bone-marrow 

micronucleus assay and a bacterial DNA 

damage or repair assay. Based on the 

results of these studies, EPA has 

classified novaluron as ‘‘not likely to be 

carcinogenic to humans.’’ 

Specific information on the studies 

received and the nature of the adverse 

effects caused by novaluron as well as 

the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in the document 

‘‘Novaluron: Human-Health Risk 

Assessment for Proposed Section 3 Uses 

on Vegetable, Fruiting, Group 8; 

Vegetable, Cucurbit, Group 9; Berry, 

Low-growing, Subgroup 13-07G; 

Miscellaneous Fruiting Vegetables; 

Bean, Snap; Bean, Dry, Seed; and Swiss 

Chard,’’ pages 27–30 in docket ID 

number EPA–HQ–OPP–2009–0273. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a benchmark dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-term, intermediate-term, 

and chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the level of concern (LOC). 

For non-threshold risks, the Agency 

assumes that any amount of exposure 

will lead to some degree of risk. Thus, 

the Agency estimates risk in terms of the 


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probability of an occurrence of the 

adverse effect greater than that expected 

in a lifetime. For more information on 

the general principles EPA uses in risk 

characterization and a complete 

description of the risk assessment 

process, see http://www.epa.gov/ 

pesticides/factsheets/riskassess.htm. 

A summary of the toxicological 

endpoints for novaluron used for human 

risk assessment can be found at http:// 

www.regulations.gov in the document 

‘‘Novaluron: Human-Health Risk 

Assessment for Proposed Section 3 Uses 

on Vegetable, Fruiting, Group 8; 

Vegetable, Cucurbit, Group 9; Berry, 

Low-growing, Subgroup 13-07G; 

Miscellaneous Fruiting Vegetables; 

Bean, Snap; Bean, Dry, Seed; and Swiss 

Chard,’’ pages 12–13 in docket ID 

number EPA–HQ–OPP–2009–0273. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to novaluron, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

novaluron tolerances in 40 CFR 180.598. 

EPA assessed dietary exposures from 

novaluron in food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1–day or single 

exposure. No such effects were 

identified in the toxicological studies 

for novaluron; therefore, a quantitative 

acute dietary exposure assessment is 

unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

Continuing Surveys of Food Intakes by 

Individuals (CSFII). As to residue levels 

in food, EPA incorporated anticipated 

residues derived from average field trial 

residues for pome fruit, sugarcane, 

bushberry, Brassica leafy greens, stone 

fruit, bell pepper, non-bell pepper, 

cucumber, summer squash, cantaloupe, 

strawberry, succulent snap bean, dry 

bean seed, and Swiss chard; average 

greenhouse trial residues for tomato; 

empirical processing factors for apple 

juice (translated to pear and stone fruit 

juice), tomato paste and pure`e; and 

Dietary Exposure Evaluation Modeling 

(DEEM) default processing factors for 

the remaining processed commodities. 

In estimating dietary exposure from 

secondary residues in livestock, EPA 

relied on anticipated residues for meat, 

hog, and milk commodities. Onehundred percent crop treated (PCT) was 

assumed for all existing and new uses 

of novaluron. 

iii. Cancer. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

EPA has classified novaluron as ‘‘not 

likely to be carcinogenic to humans.’’ 

Therefore, a quantitative exposure 

assessment to evaluate cancer risk is 

unnecessary. 

iv. Anticipated residue information. 

Section 408(b)(2)(E) of FFDCA 

authorizes EPA to use available data and 

information on the anticipated residue 

levels of pesticide residues in food and 

the actual levels of pesticide residues 

that have been measured in food. If EPA 

relies on such information, EPA must 

require pursuant to FFDCA section 

408(f)(1) that data be provided 5 years 

after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. For the present 

action, EPA will issue such data call-ins 

as are required by FFDCA section 

408(b)(2)(E) and authorized under 

FFDCA section 408(f)(1). Data will be 

required to be submitted no later than 

5 years from the date of issuance of 

these tolerances. 

2. Dietary exposure from drinking 

water. The residues of concern in 

drinking water are novaluron and its 

chlorophenyl urea and chloroaniline 

degradates. The Agency used screening 

level water exposure models in the 

dietary exposure analysis and risk 

assessment for novaluron and its 

degradates in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of novaluron. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www.epa.gov/oppefed1/models/ 

water/index.htm. 

The following models were used to 

assess residues of concern in drinking 

water: the Pesticide Root Zone Model/ 

Exposure Analysis Modeling System 

(PRZM/EXAMS) for parent novaluron in 

surface water; the First Index Reservoir 

Screening Tool (FIRST) for 

chlorophenyl urea and chloroaniline 

degradates in surface water; and the 

Screening Concentration in Ground 

Water (SCI-GROW) model for 

novaluron, chlorophenyl urea and 

chloroaniline in ground water. The 

estimated drinking water concentrations 

(EDWCs) of novaluron, chlorophenyl 

urea, and chloroaniline for chronic 

exposures for non-cancer assessments 

are estimated to be 0.76 parts per billion 

(ppb), 0.89 ppb and 2.6 ppb, 

respectively, for surface water and 

0.0056 ppb, 0.0045 ppb and 0.0090 ppb, 

respectively, for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. The 

highest drinking water concentrations 

were estimated for surface water. Of the 

three EDWC values for surface water, 

the chronic EDWC for the terminal 

metabolite, chloroaniline, is the highest 

(assuming 100% molar conversion from 

parent to aniline). This is consistent 

with the expected degradation pattern 

for novaluron. Therefore, for chronic 

dietary risk assessment, the water 

concentration value for chloroaniline of 

2.6 ppb was used to assess the 

contribution to drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). Novaluron 

is not registered for any specific use 

patterns that would result in residential 

exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found novaluron to share 

a common mechanism of toxicity with 

any other substances, and novaluron 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that novaluron does not have 

a common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 


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safety is commonly referred to as the 

FQPA SF. In applying this provision, 

EPA either retains the default value of 

10X, or uses a different additional safety 

factor when reliable data available to 

EPA support the choice of a different 

factor. 

2. Prenatal and postnatal sensitivity. 

The prenatal and postnatal toxicology 

database for novaluron includes rat and 

rabbit prenatal developmental toxicity 

studies and a 2–generation reproduction 

toxicity study in rats. There was no 

evidence of increased quantitative or 

qualitative susceptibility following in 

utero exposure to rats or rabbits in the 

developmental toxicity studies and no 

evidence of increased quantitative or 

qualitative susceptibility of offspring in 

the reproduction study. Neither 

maternal nor developmental toxicity 

was seen in the developmental studies 

up to the limit doses. In the 

reproduction study, offspring and 

parental toxicity (increased absolute and 

relative spleen weights) were similar 

and occurred at the same dose; 

additionally, reproductive effects 

(decreases in epididymal sperm counts 

and increased age at preputial 

separation in the F1 generation) 

occurred at a higher dose than that 

which resulted in parental toxicity. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for novaluron 

is complete except for immunotoxicity 

testing. Recent changes to 40 CFR part 

158 make immunotoxicity testing 

(OPPTS Guideline 870.7800) required 

for pesticide registration; however, the 

existing data are sufficient for endpoint 

selection for exposure/risk assessment 

scenarios, and for evaluation of the 

requirements under the FQPA. 

Although effects were seen in the spleen 

in two studies, as explained in Unit 

III.A., EPA has concluded that 

novaluron does not directly target the 

immune system and the Agency does 

not believe that conducting a functional 

immunotoxicity study will result in a 

NOAEL lower than the regulatory dose 

for risk assessment; therefore, an 

additional database uncertainty factor is 

not needed to account for potential 

immunotoxicity. 

ii. There were signs of neurotoxicity 

in the acute neurotoxicity study in rats, 

including clinical signs (piloerection, 

fast/irregular breathing), functional 

observation battery (FOB) parameters 

(head swaying, abnormal gait), and 

neuropathology (sciatic and tibial nerve 

degeneration). However, the signs 

observed were not severe, were seen 

only at the limit dose (2,000 milligrams/ 

kilogram/day (mg/kg/day)) and were not 

reproducible. No signs of neurotoxicity 

or neuropathology were observed in the 

subchronic neurotoxicity study in rats at 

doses up to 1,752 mg/kg/day in males 

and 2,000 mg/kg/day in females or in 

any other subchronic or chronic toxicity 

study in rats, mice or dogs, including 

the developmental and reproduction 

studies. Therefore, novaluron does not 

appear to be a neurotoxicant, and there 

is no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. 

iii. There is no evidence that 

novaluron results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2–generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level or anticipated residues 

derived from reliable residue field trials. 

EPA made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to novaluron in drinking water. 

Residential exposures are not expected. 

These assessments will not 

underestimate the exposure and risks 

posed by novaluron. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases given the 

estimated aggregate exposure. Shortterm, intermediate-term, and chronicterm risks are evaluated by comparing 

the estimated aggregate food, water, and 

residential exposure to the POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single-oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, novaluron is not 

expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to novaluron from 

food and water will utilize 84% of the 

cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. There are no residential uses 

for novaluron. 

3. Short-term and intermediate-term 

risk. Sort-term and intermediate-term 

aggregate exposure takes into account 

short-term and intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Novaluron is not registered for any use 

patterns that would result in residential 

exposure. Therefore, the short-term and 

intermediate-term aggregate risk is the 

sum of the risk from exposure to 

novaluron through food and water and 

will not be greater than the chronic 

aggregate risk. 

4. Aggregate cancer risk for U.S. 

population. There was no evidence of 

carcinogenic potential in either the rat 

or mouse carcinogenicity studies and no 

evidence of mutagenic activity in the 

submitted mutagenicity studies; 

therefore, novaluron is not expected to 

pose a cancer risk to humans. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to novaluron 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

The following adequate enforcement 

methodologies are available to enforce 

the tolerance expression: A gas 

chromatography/electron-capture 

detection (GC/ECD) method and a highperformance liquid chromatography/ 

ultraviolet (HPLC/UV) method. The 

methods may be requested from: Chief, 

Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; email address: residuemethods@epa.gov. 

B. International Residue Limits 

There are no Codex, Canadian or 

Mexican maximum residue limits 

established for residues of novaluron on 

commodities associated with this 

petition. 

C. Revisions to Petitioned-for Tolerances 

Based on analysis of the residue field 

trial data supporting the petition, EPA 

revised the proposed tolerances on 

vegetable, cucurbit, group 9 from 0.25 

ppm to 0.15 ppm; berry, low growing, 

subgroup 13-07G, except lowbush 


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4278 Federal Register / Vol. 75, No. 17 / Wednesday, January 27, 2010 / Rules and Regulations 

blueberry from 0.50 ppm to 0.45 ppm; 

bean, dry, seed from 0.20 ppm to 0.30 

ppm; and the following commodities 

from 1.1 ppm to 1.0 ppm: vegetable, 

fruiting, group 8; cocona; eggplant, 

African; eggplant, pea; eggplant, scarlet; 

goji berry; huckleberry, garden; 

martynia; naranjilla; okra; roselle; 

sunberry; tomato, bush; tomato, currant; 

and tomato, tree. EPA revised these 

tolerance levels based on analysis of the 

residue field trial data using the 

Agency’s Tolerance Spreadsheet in 

accordance with the Agency’s Guidance 

for Setting Pesticide Tolerances Based 

on Field Trial Data. EPA also revised 

the entry for berry, low growing, 

subgroup 13-07G to exclude lowbush 

blueberry. Lowbush blueberry is 

included as a member of bushberry 

subgroup 13-07B, which has an 

established tolerance for novaluron at 

7.0 ppm; therefore, because the 

established subgroup 13-07B tolerance 

is higher (at 7.0 ppm), EPA has 

excluded lowbush blueberry from 

subgroup 13-07G (at 0.45 ppm). 

V. Conclusion 

Therefore, tolerances are established 

for residues of novaluron, N-[[[3-chloro4-[1,1,2-trifluoro-2-(trifluoromethoxy)

ethoxy]phenyl]amino]carbonyl]-2,6- 

difluorobenzamide, in or on vegetable, 

fruiting, group 8 at 1.0 ppm; vegetable, 

cucurbit, group 9 at 0.15 ppm; berry, 

low growing, subgroup 13-07G, except 

lowbush blueberry at 0.45 ppm; cocona 

at 1.0 ppm; eggplant, African at 1.0 

ppm; eggplant, pea at 1.0 ppm; eggplant, 

scarlet at 1.0 ppm; goji berry at 1.0 ppm; 

huckleberry, garden at 1.0 ppm; 

martynia at 1.0 ppm; naranjilla at 1.0 

ppm; okra at 1.0 ppm; roselle at 1.0 

ppm; sunberry at 1.0 ppm; tomato, bush 

at 1.0 ppm; tomato, currant at 1.0 ppm; 

tomato, tree at 1.0 ppm; bean, snap, 

succulent at 0.60 ppm; bean, dry, seed 

at 0.30 ppm; and Swiss chard at 12 

ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: January 19, 2010. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.598 is amended by: 

■ i. Removing the entry for ‘‘Tomato’’ 

from the table in paragraph (a); and 

■ ii. Alphabetically adding the 

following commodities to the table in 

paragraph (a) to read as follows: 

§ 180.598 Novaluron; tolerances for 

residues. 

(a) * * * 

Commodity Parts per million 

* * * * * 

Bean, dry, seed .............. 0.30 

Bean, snap, succulent .... 0.60 

Berry, low growing, subgroup 13-07G, except 

lowbush blueberry ....... 0.45 

* * * * * 

Cocona ........................... 1.0 

* * * * * 

Eggplant, African ............ 1.0 

Eggplant, pea ................. 1.0 

Eggplant, scarlet ............. 1.0 

* * * * * 

Goji berry ........................ 1.0 

* * * * * 

Huckleberry, garden ....... 1.0 

Martynia .......................... 1.0 

* * * * * 

Naranjilla ......................... 1.0 

Okra ................................ 1.0 

* * * * * 

Roselle ............................ 1.0 

* * * * * 

Sunberry ......................... 1.0 

Swiss chard .................... 12 

Tomato, bush .................. 1.0 

Tomato, currant .............. 1.0 

Tomato, tree ................... 1.0 

* * * * * 

Vegetable, cucurbit, 

group 9 ........................ 0.15 


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Federal Register / Vol. 75, No. 17 / Wednesday, January 27, 2010 / Rules and Regulations 4279 

Commodity Parts per million 

Vegetable, fruiting, group 

8 .................................. 1.0 

* * * * * 

* * * * * 

[FR Doc. 2010–1609 Filed 1–26–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0876; FRL–8804–2] 

Pendimethalin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues or 

residues of pendimethalin, N-(1- 

ethylpropyl)-3,4-dimethyl-2,6- 

dinitrobenzenamine, in or on grass 

forage, fodder, and hay crop group 17, 

forage; grass forage, fodder, and hay 

crop group 17, hay; and grass forage, 

fodder, and hay crop group 17, straw. 

BASF Corporation requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

January 27, 2010. Objections and 

requests for hearings must be received 

on or before March 29, 2010, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2008–0876. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: Phil 

Errico, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6663; e-mail address: 

errico.philip@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Get Electronic Access to 

Other Related Information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

cite at http://www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2008–0876 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before March 29, 2010. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2008–0876, by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Petition for Tolerance 

In the Federal Register of April 13, 

2009 (74 FR 16866) (FRL–8396–6), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 8F7396) by BASF 

Corporation, 26 Davis Drive, Research 

Triangle Park, NC 27709–3528. The 

petition requested that 40 CFR 180.361 

be amended by establishing tolerances 

for combined residues of the herbicide, 

pendimethalin, N-(1-ethylpropyl)-3,4- 

dimethyl-2,6-dinitrobenzenamine, and 

its metabolite 4-[(1-ethylpropyl)amino]- 

2-methyl-3,5-dinitrobenzyl alcohol, 

expressed as the stoichiometric 

equivalent of pendimethalin, in or on 

grass forage, fodder, and hay crop group 

17, forage; grass forage, fodder, and hay 

crop group 17, hay; and grass forage, 

fodder, and hay crop group 17, straw at 

40 parts per million (ppm), 80 ppm, and 

4.5 ppm, respectively. That notice 

referenced a summary of the petition 

prepared by BASF Corporation, the 

registrant, which is available to the 

public in the docket, at http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 


hsrobinson on DSK69SOYB1PROD with RULES